A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants

NCT04578535 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TAK-771-1001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the tolerability, safety, and pharmacokinetics of HYQVIA with ramp-up and no ramp-up dosing in healthy adult participants.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Tolerated All Initiated HYQVIA Infusion

  A tolerability event was considered to have occurred if an infusion was tolerable. An infusion was considered tolerable if the infusion rate was not reduced, or the infusion was not interrupted or stopped, due to an adverse event (AE) related to HYQVIA infusion. Tolerability was measured in terms of the number of participants for which the infusions was tolerable. Number of participants who tolerated all initiated HYQVIA Infusion were reported.

  From start of the study drug administration up to Week 9

Secondary Outcomes (8)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  From start of the study drug administration up to Week 25

• Number of Participants Who Developed Binding and Neutralizing Antibodies to Recombinant Human Hyaluronidase PH20 (rHuPH20)

  From start of the study drug administration up to Week 25

• Time of Maximum Observed Serum Concentration (Tmax) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

  Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6

• Maximum Observed Serum Concentration (Cmax) Sampled During a Dosing Interval of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

  Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6

• Area Under the Curve From the Time of Dosing to the Last Time Point With Measurable Concentration (AUClast) of Total IgG and IgG Subclasses (IgG1, IgG2, IgG3, IgG4)

  Pre-dose (Day 1), and 48, 96, 144 and 192 hours post-dose for all treatment arms; 360 hours post-dose for treatment arms 2 and 5; 360 and 696 hours post-dose for treatment arms 3 and 6

Study Arms (6)

Part 1 Schedule A: TA 1 (Low TDL HYQVIA)

EXPERIMENTAL

Participants received a subcutaneous (SC) infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.

Drug: HYQVIA

Part 2 Schedule A: TA 4 (High TDL HYQVIA)

EXPERIMENTAL

Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.

Drug: HYQVIA

Part 1 Schedule B: TA 2 (Low TDL HYQVIA)

EXPERIMENTAL

Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.

Drug: HYQVIA

Part 2 Schedule B: TA 5 (High TDL HYQVIA)

EXPERIMENTAL

Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.

Drug: HYQVIA

Part 1 Schedule C: TA 3 (Low TDL HYQVIA)

EXPERIMENTAL

Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.

Drug: HYQVIA

Part 2 Schedule C: TA 6 (High TDL HYQVIA)

EXPERIMENTAL

Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.

Drug: HYQVIA

Interventions

HYQVIA DRUG

Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.

Also known as: IGI 10% with rHuPH20, Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

Part 1 Schedule A: TA 1 (Low TDL HYQVIA)

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• An understanding, ability, and willingness to fully comply with study procedures and restrictions
• Ability to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent to participate in the study
• Male, or non-pregnant, non-breastfeeding female who agrees to comply with any applicable contraceptive requirements of the protocol, or females of non-childbearing potential
• Must be considered "healthy". Healthy as determined by the investigator on the basis of screening evaluations and healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electro cardiogram (ECG), hematology, blood chemistry, and urinalysis
• Body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m\^2) inclusive

You may not qualify if:

• Any current or relevant history of medical (e.g. any hematological, hepatic, respiratory, cardiovascular, renal or neurological) or psychiatric conditions, which by judgment of the investigator might compromise the safety of the participant or integrity of the study, interfere with the participant's participations in the trial and compromise the trial objectives or any condition that presents undue risk from the investigational product or procedures Note: Participants on stable dose of hormone replacements (i.e. thyroid hormone replacement) or oral contraceptives are permitted
• Clinically significant cardiac conditions including but not limited to uncontrolled hypertension, myocardial infarction, unstable coronary artery disease and clinically significant arrhythmias and conduction disorders
• Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients (e.g. human IG, hyaluronidase, albumin)
• Known history of hypersensitivity or severe allergic reactions (e.g. urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following administration of blood or blood components
• Significant illness, as judged by the investigator, within 30 days of the first dose of investigational product
• Known history of alcohol or other substance abuse within the last year
• Donation of blood within 60 days, or blood products (e.g., plasma or platelets) within 2 weeks prior receiving the first dose of investigational product
• Participants will be excluded if any of the following laboratory parameters meet the criteria below:
• Hemoglobin less than (\<) 11 gram per deciliter (g/dL). Absolute neutrophil count less than or equal to (\< or =) 1500/ cubic millimeter (mm\^3) and platelet count less than or equal to (\< or =) 100,000/mm\^3 Liver function: alanine aminotransferase (ALT) greater than or equal to \> or =2.5 × upper limit normal (ULN), aspartate aminotransferase (AST) \> or =2.5 × upper limit normal (ULN), alkaline phosphatase \> or =1.5 × ULN or total bilirubin \> or =1.5 milligram per deciliter (mg/dL) Renal function: creatinine clearance \<or= 60 milliliter per minute (mL/min) based on Cockcroft-Gault equation Coagulation tests: activated partial thromboplastin time (aPTT) \>1.2 X ULN; international normalized ratio (INR) \>1.2 Participants will be excluded if any other laboratory values are outside the reference range and are clinically significant per investigator's judgment.
• Within 30 days prior to the first dose of investigational product:
• Has participated in another clinical study involving immunoglobulin products within 12 months of screening.
• Have used an investigational product (or 5 half-lives, whichever is longer).
• Have been enrolled in a clinical study (including vaccine studies or has been vaccinated with approved product) that, in the investigator's opinion, may impact this study. Participants who have received any vaccine (including live attenuated vaccines) during the last 30 days before dosing will be excluded. No live attenuated virus vaccines are allowed during the study until the end of the follow up period
• Have had any substantial changes in eating habits, as assessed by the investigator.
• Confirmed systolic blood pressure \>139 mmHg or \<89 mmHg and diastolic blood pressure \>89 mmHg or \<49 millimeters of Mercury (mmHg)

Sponsors & Collaborators

• Baxalta now part of Shire: lead
• Baxalta Innovations GmbH, now part of Shire: collaborator

Study Sites (1)

Clinical Pharmacology of Miami, Inc

Hialeah, Florida, 33014, United States

Location

Related Links

• To obtain more information on the study, click here/on this link

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@takeda.com

+1 866 842 5335

Study Officials

• Study Director

  Shire

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: October 8, 2020
• Study Start: October 27, 2020
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: December 14, 2023
• Results First Posted: December 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (1)